GENERAL SEMEN ANALYSIS (GSA) KIT


Device Classification Name

counter, differential cell

510(k) Number K024337
Device Name GENERAL SEMEN ANALYSIS (GSA) KIT
Original Applicant
BIOSHAF LTD.
16809 briardale rd.
rockville, 
MD 
20855

Original Contact tom tsakeris
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 12/27/2002
Decision Date 07/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No